An FDA advisory panel yesterday recommended that the federal safety watchdog approve a device made by TransMedics to keep donated lungs perfused during transport to transplantation procedures.
The FDA’s Gastroenterology & Urology Devices panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, an FDA spokeswoman told MassDevice.com via email.
TransMedics did not respond to a request for comment.
A previously scheduled advisory panel hearing for another TransMedics device, the OCS Heart system, was cancelled by the FDA in November 2015. The agency told MassDevice.com at the time that “FDA has determined that an advisory committee is no longer needed to discuss the premarket approval application” for the OCS Heart device.
In February 2016 TransMedics launched a pivotal study of its OCS Liver device, comparing compare liver transplantation using the the device with the standard of care – transplantation using a liver preserved on ice. The primary endpoints are incidence of early liver allograft dysfunction at 7 days and incidence of liver graft-related serious adverse events at 30 days. Final data collection for the primary endpoint is slated for October.
Last July TransMedics added nearly $13 million to a $51 million equity round.